Thoratec HeartMate III, Instructions For Use Manual, Page: 13 / 458

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-3
Preface
This manual contains information needed to properly and safely operate the HeartMate III™
Left Ventricular Assist System. Users of the HeartMate III Left Ventricular Assist System should
have a practical knowledge of the principles of mechanical circulatory support, and should be
aware of the physiological and psychological needs of a patient undergoing mechanical
ventricular support. New users should read this document in its entirety before system operation.
For experienced practitioners, this manual may serve as a reference.
As with all prescription medical devices, clinical procedures should be conducted under the
direction of the prescribing physician. The professional staff at Thoratec
®
Corporation regularly
provides laboratory training and on-site, in-service programs.
Understanding Warnings and Cautions
In this manual, warnings and cautions that are relevant to a specific procedure or piece of
equipment appear at the start of each applicable section.
Warnings refer to actions or hazardous conditions that could cause serious injury or death if not
avoided. Ignoring a warning can cause sudden and serious injury, life-threatening harm, or
death for the user or patient.
Cautions refer to actions or potentially unsafe conditions that may cause injury to a patient or
user, damage the equipment, or affect how the system works. Ignoring a caution can cause the
patient or user injury, or result in equipment failure or sub-optimal system operation. Although
important for maximum safety and optimal system function, usually cautions do not refer to
life-threatening risks.
WARNING !
Warnings appear in the manual in this format.
CAUTION !
Cautions appear in the manual in this format.